A bio-pharmaceutical organisation in the Irish market is expanding their global manufacturing operations on one of their Dublin based sites.
This is a CSV Engineering position within the site project team. You will contribute to the activities within various projects for identified project streams including integrated MES, LIMS, OSI-PI Historian, equipment integration, and network configuration. The CSV Engineer will report to the Project Manager or Senior CSV Engineer for work assignment. Close collaboration is required with site QA Validation representative(s) in the development of project CSV deliverables
- GxP Risk Assessment development in collaboration with Systems SME's and in alignment with GxP Computerised Systems good practice and Takeda procedures.
- Validation Master Plan development.
- Validation Protocols development (including IQ/OQ/PQ documentation).
- Validation protocol execution oversight, review, and witnessing where appropriate based on GxP risk
- Validation report development.
- Test script development where required to supplement SME test scripts.
- Reviewing test scripts written by SME's Review of systems change controls as required.
- Completion of additional quality documentation/forms as required by Takeda procedures.
- Assisting with other project documentation including but not limited to SOP gap analyses, design reviews/DQ, and go live planning etc.
- All applications must have a Degree in Engineering with a minimum of 4 years' experience working within quality/compliance/validation in the pharmaceutical industry.
- Experience in MES validation planning and execution within a full end-to-end project life cycle is a must, ideally involving PAS-X MES (v3).
- Must have a strong understanding of waterfall and iterative System Development Life Cycles aligned with industry good practice.
- Competitive hourly rate on offer.
- Remote working options.
To discover more about this opportunity, apply now or contact Emma Mullen at HRM on +353 87 6369263 for a confidential discussion.